ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effectivity of Dermatix in Promoting Scar Maturation

This study is currently recruiting participants.
Verified by Association of Dutch Burn Centres, October 2007

Sponsors and Collaborators: Association of Dutch Burn Centres
Valeant Pharmaceuticals International
Information provided by: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00548210
  Purpose

The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.


Condition Phase
Hypertrophic Scars
Phase III

MedlinePlus related topics:   Scars   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Dermatix; A Randomized Controlled Trial Measuring Effectivity of Dermatix in Promoting Scar Maturation of Hypertrophic Scars.

Further study details as provided by Association of Dutch Burn Centres:

Estimated Enrollment:   25

Detailed Description:

The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited.

Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations.

Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars.

Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
  2. Written informed consent
  3. Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
  4. Patients of 18 years or older

Exclusion criteria:

  1. Known sensitivity for occlusive dressings or silicone containing products
  2. Any patient condition that may influence the compliance of the treatment negatively.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548210

Contacts
Contact: Antoon van den Bogaerdt, PhD     +31 251 264917     AvdBogaerdt@rkz.nl    
Contact: Esther Middelkoop, PhD     +31 251 265283     EMiddelkoop@rkz.nl    

Locations
Netherlands, Noord-Holland
Association of Dutch Burn Centres     Recruiting
      Beverwijk, Noord-Holland, Netherlands, 1940 EB
      Contact: Antoon van den Bogaerdt, PhD     +31 251 264917     AvdBogaerdt@rkz.nl    
      Contact: Esther Middelkoop, PhD     +31 251 264917     EMiddelkoop@rkz.nl    
      Principal Investigator: Antoon van den Bogaerdt, PhD            

Sponsors and Collaborators
Association of Dutch Burn Centres
Valeant Pharmaceuticals International

Investigators
Study Director:     Esther Middelkoop, PhD     Association of Dutch Burn Centres    
  More Information


Study ID Numbers:   DERMO0501
First Received:   October 22, 2007
Last Updated:   October 22, 2007
ClinicalTrials.gov Identifier:   NCT00548210
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
Hypertrophy  
scarring  
scar treatment  
silicone  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hypertrophy
Cicatrix, Hypertrophic
Skin Diseases
Cicatrix

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers